I have returned from attending the "International Workshop to Evaluate Research
Needs on the Use and Safety of Medicinal Herbs."

The following is a synopsis of issues that were discussed:

There is currently little standardization of herbals.  An example is St. John's
wort.  Products range from 150 mg to 400 mg dosage strengths.  Within these
dosage strengths, there is up to a 10x fold difference in potency with 20% to
130% of labeled amounts of hypericum, the active ingredient.
There is little information on herbal risks, adverse effects, and drug/food
interactions.
There may be multiple ingredients in specific herbal preparations or even worse,
NO active ingredient(s) at all.
There is a need to look at ALL literature and data, to look at ALL chemicals in
the plant and the pharmacology of ALL possible chemical components.  This needs
to be done on a class by class basis.
No toxicological studies are available on herbals, but common sense over the
ages by people using herbals should tell us by now what herbals are safe or
toxic.
Main toxic effects of herbals that have these effects are on the immune system
and the liver.

The German Commission-E monographs consist of expert panel reviews of all
available data, but are not referenced.  This information is placed in all
package inserts for patent guidance.  It consists of claimed areas of
application/use, contraindications, side effects, and daily dosage.  Claimed
safety is absolute but does not consist of carcinogenic data.  Claims of use are
reasonably certain. (Note: Kava is listed as contraindicated in lactation in its
monograph)

The National Nutritional Foods Association (USA) has 1,000 members and a 30,000
product database.  It is attempting to identify ingredients, standardize testing
methods, determine potency, and evaluate clinical trials of herbals.  There have
been clinical trials on St. John's wort, ginkgo (for dementia), and garlic.

For research on herbals, it is critical to identify the plant part used and to
identify the herbal by its Latin binomial name.

Only one researcher mentioned any observations of adverse effects on breastfed
infants.  There was a paucity of information on the use of herbals by
breastfeeding mothers.  Fenugreek is not one of the top 20 used herbals in the
USA, and the meeting attendees were unfamiliar with its use as a lactagogue.

I spoke on the need for more research in the area of herbals and breastfeeding.
I gave my business card out to members of the discussion panel which included
representatives from government, academia, and private industry.  Several
representatives from trade or herbal associations approached me with the
possibility of working with the breastfeeding community on this issue. Money to
do research in this area was given as the main limiting factor.

The German Commission-E monographs have finally been translated into English.
Also, there is now a PDR on herbals.  I have ordered both publications and will
review them for any possible breastfeeding information and data.

As you can see, there is a need for much more research in the whole general area
of herbals let alone in the breastfeeding arena.  One expert I talked with said
he thought that the whole herbal fad will be over in five years when we discover
that they are generally safe, but do not really work too well.

Frank J. Nice, DPA, CPHP